Contact Information: Contacts: Alan Husband + 61 2 9878 0088 (Australia) Warren Lancaster 203 966 2556
Yale Researchers Present Results of Phase II Phenoxodiol Clinical Trial in Prostate Cancer Patients at ASCO 2009 Genitourinary Cancers Symposium
| Source: Marshall Edwards, Inc.
ORLANDO, FL--(Marketwire - February 24, 2009) - Marshall Edwards, Inc. (NASDAQ : MSHL ) --
Preliminary results from a Phase II clinical trial of oral phenoxodiol in
patients with prostate cancer to be presented by Yale researchers at the
ASCO Genitourinary Cancers Symposium in Orlando, Florida, February 26-28,
2009 became available in abstract form on the ASCO website today. The
research was led by Kevin Kelly, DO, Associate Director, Solid Tumor
Investigation, Yale Cancer Center.
The abstract relates to a poster presentation which will review data
supporting the anti-tumor effects of phenoxodiol as studied in patients
with advanced prostate cancer (Group A) and in patients with early stage,
pre-metastatic disease where prostate specific antigen (PSA) levels were
rising after radical prostatectomy or radiation therapy (Group B). Twenty
five (25) patients have been treated to date -- 16 in Group A and 9 in
Group B. Interim analysis shows that among Group A patients, 1 remains on
therapy without disease progression for greater than 6 months and 1 patient
had a greater than 50% post-therapy PSA decline, while 5 patients in Group
B (56%) had stable disease for a median time of 3 months.
"Oral phenoxodiol was very well tolerated with no severe adverse events
reported to date. More importantly, we observed some evidence of clinical
activity, especially in the early stage disease group, in terms of holding
disease progression in check," said Dr. Kelly. "Further studies evaluating
the impact of phenoxodiol on serum cytokines will be explored at the
completion of the trial."
In another related development concerning the potential for phenoxodiol as
a therapeutic in prostate cancer, a paper was published today in the
British Journal of Cancer reporting that, in addition to its potential as a
single agent therapeutic, phenoxodiol is able to enhance the activity of
cisplatin and carboplatin against prostate cancer cells in vitro(1). This
study, conducted by Professor Paul de Souza and colleagues of the
Department of Medical Oncology at St. George Hospital in Sydney, Australia
concluded "that phenoxodiol has interesting properties that make
combination therapy with cisplatin or carboplatin appealing."
About phenoxodiol:
Phenoxodiol is being developed by the US oncology company Marshall Edwards,
Inc. (NASDAQ : MSHL ) as a chemosensitizing agent in combination with
platinum drugs for late stage, chemoresistant ovarian cancer and as a
monotherapy for prostate and cervical cancers. It has a unique mechanism of
action, binding to cancer cells via a surface oxidase, causing major
downstream disturbances in expression of proteins necessary for cancer cell
survival and responsible for the development of drug resistance.
In cancer cells, phenoxodiol appears to selectively inhibit the
pro-survival regulator known as S-1-P
(sphingosine-1-phosphate) that is overexpressed in cancer cells. In
response to phenoxodiol, the S-1-P content in cancer cells is decreased,
rendering those cells more sensitive to chemotherapy. Indeed, in laboratory
studies, it has been demonstrated that cancer cells pre-treated with
phenoxodiol were killed with lower doses of chemotherapy drugs.
Importantly, phenoxodiol has been shown not to adversely affect normal
cells in animal and laboratory testing. Phenoxodiol has received Fast Track
status from the FDA to facilitate its development as a therapy for
recurrent ovarian and prostrate cancers. Phenoxodiol is an investigational
drug and, as such, is not commercially available. Under U.S. law, a new
drug cannot be marketed until it has been investigated in clinical trials
and approved by the FDA as being safe and effective for the intended use.
Phenoxodiol is the first of a family of compounds in the Marshall Edwards,
Inc. drug pipeline of flavanoid derivatives.
Phase III Phenoxodiol Clinical Trial for Ovarian Cancer Continues
The OVArian TUmor REsponse (OVATURE) trial is a major multi-center
multinational Phase III clinical trial of orally administered phenoxodiol
in combination with carboplatin in women with advanced ovarian cancer
resistant or refractory to platinum-based drugs, to determine its safety
and effectiveness when used in combination with carboplatin. More
information on the trial can be found at http://www.OVATUREtrial.com.
The OVATURE trial is recruiting ovarian cancer patients whose cancer
initially responded to chemotherapy, but has since become resistant or
refractory to traditional platinum treatments. The trial consists of two
double blind treatment arms. Patients in one trial arm are receiving weekly
carboplatin and phenoxodiol. Patients in the other trial arm are also
receiving weekly carboplatin, but a placebo (an inactive control pill) is
substituted for phenoxodiol. Neither patients nor their doctors know to
which trial arm the patients are randomly assigned.
A change from receiving platinum in the traditional dose pattern (every two
to three weeks) to a weekly dosing regimen has been reported to provide a
tumor response in some patients with recurrent ovarian cancer.(2-4) Thus,
in addition to learning more about the safety and efficacy of phenoxodiol,
researchers will learn more about the efficacy and safety of weekly
carboplatin.
The primary outcome of the trial is the assessment of the relative time it
takes for the ovarian cancer to progress. An analysis of interim results
will be possible after patient recruitment to this study is completed and
95 patients have disease progression.
Patients are being recruited at hospital sites across the USA, UK, Europe
and Australia. The trial design has been approved by the US Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) program, and
provides for an interim analysis of the data, which, if statistically
significant, can be used to support a request for accelerated marketing
approval.
About Marshall Edwards, Inc.
Marshall Edwards, Inc. is a specialist oncology company focused on the
clinical development of novel anti-cancer therapeutics. These derive from a
flavonoid technology platform, which has generated a number of novel
compounds characterized by broad ranging activity against a range of cancer
cell types with few side effects. The combination of anti-tumor cell
activity and low toxicity is believed to be a result of the ability of
these compounds to target an enzyme present in the cell membrane of cancer
cells, thereby inhibiting the production of pro-survival proteins within
the cell. Marshall Edwards has licensed rights from Novogen Limited (ASX : NRT ) (NASDAQ : NVGN ) to bring three oncology drugs -- phenoxodiol,
triphendiol and NV-143 -- to market globally. Marshall Edwards' lead
investigational drug, phenoxodiol, is in a Phase III multinational
multi-centered clinical trial for patients with recurrent ovarian cancer.
More information on the trial can be found at http://www.OVATUREtrial.com.
Marshall Edwards is majority owned by Novogen, Limited (ASX : NRT ) (NASDAQ : NVGN ), an Australian biotechnology company that is specializing in the
development of therapeutics based on a flavonoid technology platform. More
information on phenoxodiol and on the Novogen group of companies can be
found at www.marshalledwardsinc.com and www.novogen.com.
(1) McPherson, R.A., Galettis, P.T. and de Souza, P.L.. Enhancement of the
activity of phenoxodiol by cisplatin in prostate cancer cells. Br.J.Cancer
2009; 100 (4):649-655.
(2) Piura B and Meirovitz M. Weekly single-agent carboplatin in heavily
pretreated patients with recurrent ovarian, peritoneal and fallopian tube
carcinoma. Eur J Gynaecol Oncol. 2005;26(4):386-90.
(3) Van der Burg ME, van der Gaast A, Vergote I, Burger CW, van Doorn HC,
de Wit R, Stoter G, Verweij J. What is the role of dose-dense therapy? Int
J Gynecol Cancer. 2005 Nov-Dec;15 Suppl 3:233-240.
(4) CaDron I, Leunen K, Amant F, Van Grop T, Neven P, Vergote I. The Leuven
dose-dense paclitaxel/carboplatin regimen in patients with recurrent
ovarian cancer. Gynecol Oncol 2007;106(2):354-61.
Under U.S. law, a new drug cannot be marketed until it has been
investigated in clinical trials and approved by the FDA as being safe and
effective for the intended use. Statements included in this press release
that are not historical in nature are "forward-looking statements" within
the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. You should be aware that our actual results
could differ materially from those contained in the forward-looking
statements, which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not limited
to, our failure to successfully commercialize our product candidates; costs
and delays in the development and/or FDA approval, or the failure to obtain
such approval, of our product candidates; uncertainties in clinical trial
results; our inability to maintain or enter into, and the risks resulting
from our dependence upon, collaboration or contractual arrangements
necessary for the development, manufacture, commercialization, marketing,
sales and distribution of any products; competitive factors; our inability
to protect our patents or proprietary rights and obtain necessary rights to
third party patents and intellectual property to operate our business; our
inability to operate our business without infringing the patents and
proprietary rights of others; general economic conditions; the failure of
any products to gain market acceptance; our inability to obtain any
additional required financing; technological changes; government
regulation; changes in industry practice; and one-time events. We do not
intend to update any of these factors or to publicly announce the results
of any revisions to these forward-looking statements.